NCT01026233

Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Study Contact:

Study Phase:

PHASE1

Recruitment Status:

COMPLETED

NCT ID:

NCT01026233

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

Summary

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Eligibility

Inclusion Criteria:

* Relapsed or refractory CD30-positive malignancy
* Adequate organ function
* ECOG performance status \<2

Exclusion Criteria:

* Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
* Current diagnosis of primary cutaneous ALCL
* Acute or chronic graft-versus-host disease
* Prior hematopoietic stem cell transplant within specified timeframe

Disease(s) and\or Condition(s)

Disease, Hodgkin

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: brentuximab vedotin
- Description: 1.8 mg/kg IV every 21 days
- Arm Group Labels: 1

Sponsor

Seagen Inc.